BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION

    MDR report key: 4091918 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-05152
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    January 17, 2013
    Manufacturer
    ST. JUDE MEDICAL INC., CRMD
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFO PROVIDED BY MFR, NO MEDWATCH FORM WAS RECEIVED. THIS HISTORICAL COMPLAINT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINT FILES IN RESPONSE TO A RECENT FDA INSPECTION. THERE IS NO CHANGE TO THE ACTUAL PERFORMANCE OF THE PRODUCT AND THIS REPORT ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT PRESENTED IN CLINIC AFTER EXPERIENCING A VIBRATORY ALERT FOR NON-SUSTAINED RV LEAD NOISE EPISODE. THE NOISE ARTIFACT WAS PRESENT ON THE V SENSE AMP CHANNEL. THE PT WAS ASLEEP DURING THE TIME OF THE EPISODES, AND NO NEAR ANY EMI SOURCES TO HIS RECOLLECTION. NSLN PT NOTIFIER WILL BE KEPT ON AND PT WOULD BE MONITORED FOR MORE OCCURRENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33479 DURATA STS OPTIM ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL INC., CRMD 7121/65

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR